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Biomedical subjects

N G Schneider

Publications and source records attributed to N G Schneider.

At least 19 recordsLinked to original sources
PubMed2001

The nicotine inhaler: clinical pharmacokinetics and comparison with other nicotine treatments.

Nicotine inhaled in smoke is the most rapid form of delivery of the drug. With smoking, arterial boli and high venous blood nicotine concentrations are produced within seconds and minutes, respectively. The potency of nicotine as the primary reinforcement in tobacco addiction is attributed to this rapid rate of delivery. By design, nicotine treatments reduce the rate and extent of drug delivery for weaning from nicotine during smoking cessation. Theoretically, they prevent relapse by reducing withdrawal and craving associated with the abrupt cessation of cigarettes. The nicotine inhaler treats the complexity of smoking through weaning both from the drug and from the sensory/ritual components associated with smoking. The inhaler is 'puffed' but not lit and there is considerable 'puffing' required to achieve slower rising and lower nicotine concentrations. These factors allow it to be used as a nicotine reduction treatment. One inhaler contains 10 mg of nicotine (and 1 mg of menthol) of which 4 mg of nicotine can be extracted and 2mg are systemically available. Shallow or deep 'puffing' results in similar nicotine absorption. Nicotine is delivered mainly to the oral cavity, throat and upper respiratory tract with a minor fraction reaching the lungs. This was confirmed with positron emission tomography and by assessment of arterial concentrations. A single inhaler can be used for one 20-minute period of continuous puffing or periodic use of up to 400 puffs per inhaler. With controlled puffing in laboratory testing, venous plasma nicotine concentrations from a single inhaler puffed 80 times over 20 minutes averaged 8.1 microg/L at 30 minutes. Lower concentrations of 6.4 to 6.9 microg/L have been reported for self-administration under clinical conditions. The time to peak plasma concentrations varies but is always significantly longer than with cigarette delivery. Estimates of nicotine intake from cotinine concentrations were higher than expected (60 to 70% of baseline smoking concentrations). This elevation may be due to the swallowing of nicotine and subsequent first-pass biotransformation to cotinine. In general, venous blood nicotine concentrations are considerably lower than with smoking and are within the range observed for other nicotine reduction therapies. Efficacy trials show consistent superiority of the inhaler over placebo. Despite the 'cigarette-like' appearance of the inhaler and the associated sensory/ritual elements, little treatment dependence or abuse has been reported. This is attributed to the slow rise time and low nicotine blood concentrations. The inhaler is a valuable addition to treatment of tobacco dependence and can be used alone or with other treatments.

Absorption↗
PubMed1997

Saliva cotinine levels as a function of collection method.

Saliva cotinine is commonly used to estimate nicotine intake but laboratories use different methods of collection. In three small trials, comparisons were made between (1) sugar vs. unstimulated saliva production (n = 29), (2) wax chewing vs. unstimulated production (n = 15) and (3) between two consecutive unstimulated saliva samples (n = 10). Sugar-stimulated saliva cotinine scores were 26% below unstimulated levels (p < 0.001); correlation between measures was high (r = 0.90; p < 0.001). Wax stimulated saliva yielded levels 6% below unstimulated (p < 0.05; correlation: r = 0.98; p < 0.001). No differences were observed between two unstimulated samples taken within a approximately 20-minute period (correlation: r = 0.99; p < 0.001). It is postulated that changes in salivary flow can account for the findings.

Biomarkers↗
PubMed1996

Efficacy of buspirone in smoking cessation: a placebo-controlled trial.

Buspirone, a non-sedating anxiolytic, has yielded contradictory results in smoking cessation pilot studies and trials. We tested buspirone (n = 51) versus placebo (n = 49) in a placebo-controlled, double-blind trial of smoking cessation. Survival analyses were performed with use of strict abstinence criteria for efficacy (carbon monoxide levels < or = 8 ppm; no self-reported slips to smoking). No treatment differences were observed between active and placebo groups. There were also no differences among "anxiety" level groups formed post hoc from high versus low, pre-quit anxiety test scores. A number of withdrawal symptoms increased significantly after subjects quit smoking for both the active drug and placebo groups, but these symptoms were not relieved by treatment. There appears to be little evidence that buspirone is effective in smoking cessation or in the relief of withdrawal associated with cessation in a general sample. Selecting for generalized anxiety or anxiety related to cessation is suggested for future testing.

Adult↗
PubMed1996

Clinical pharmacokinetics of nasal nicotine delivery. A review and comparison to other nicotine systems.

Rapid drug delivery (arterial "boli') and high drug concentrations occur with nicotine inhaled in smoke. These are believed to be key elements in producing addiction to cigarettes. Preparations which reduce the rate of delivery and/or concentration of nicotine have been introduced as treatments for smoking cessation. These nicotine medications work by relieving withdrawal and preventing relapse associated with abrupt cessation of smoking. The pharmacokinetics of each system are expected to affect efficacy and treatment dependence. Nasal administration systems have been developed to more closely approximate cigarette delivery for improved efficacy in clinical application and for more control in systematic testing of nicotine. With laboratory tested nasal application systems (clinical drug and experimental devices), venous plasma concentrations after a single dose range between 5 and 12 micrograms/L. Higher steady-state blood nicotine concentrations (16 to 29 micrograms/L) have been reported for ad libitum clinical self-administration with a nicotine nasal spray. Time to peak plasma concentration (tmax) with nasal administration is around 11 to 13 minutes for 1 mg doses. This rise time is slower than for cigarette delivery but faster than the other nicotine treatments. Venous plasma concentrations are considerably lower than tobacco product concentrations and fall within the range of the lower dose nicotine treatments (e.g. 2 mg gum vs 4 mg gum). The profile of nasal nicotine administration was designed for certain subsets of smokers. Efficacy trials show consistent superiority of nasal administration over placebo although the comparative efficacy among nicotine treatments remains to be determined. The more rapid onset and user control of nasal nicotine may impose a higher risk for treatment dependence compared with a slower, passive system such as the patch. It may not produce more dependence than other faster-acting treatment systems (e.g. nicotine gum).

Administration, Intranasal↗
PubMed1996

Efficacy of a nicotine inhaler in smoking cessation: a double-blind, placebo-controlled trial.

A non-combustible nicotine inhaler, administered orally, has been developed for treatment of smokers. The inhaler allows weaning from nicotine while maintaining partial reinforcement of the ritual/sensory phenomena of smoking. Subjects were randomly assigned to active (n = 112) and placebo (n = 111) groups. Some behavioral intervention occurred as a function of participation. Strict abstinence (primary outcome criterion) was defined by CO < or = 8 ppm with no slips allowed at any time and cotinine values < or = 14 at 1 year. Survival analysis showed active inhaler was superior to placebo (p < 0.01). Active vs. placebo success rates were: 63% vs. 47% (day 3), 46% vs. 28% (week 1), 36% vs. 19% (week 2), 33% vs. 16% (week 3), 29% vs. 14% (week 6), 24% vs. 10% (3 months), 17% vs. 9% (6 months) and 13% vs. 8% (1 year). chi 2 analyses were significant through 3 months but not at 6 months (p < 0.08) or 1 year. Craving was relieved with active inhalers at day 3 and week 1. Subjects averaged six inhalers/day. Cotinine levels were 57-61% of smoking levels. Common side effects included throat/mouth irritation and coughing. Failure was predicted by early slips. The inhaler is clearly useful for short-term smoking cessation with potential for long-term efficacy. Extended access to the inhaler and relapse prevention training could improve success rates. Another promising approach would be to combine the inhaler with a nicotine patch.

Adult↗
PubMed1995

Efficacy of a nicotine nasal spray in smoking cessation: a placebo-controlled, double-blind trial.

Laboratory trials have demonstrated the efficacy of nicotine replacement in smoking cessation but absolute success rates are low. For many, nicotine gum is hard to use and transdermal nicotine is slow-acting and passive. A new, faster-acting nicotine nasal spray (NNS) can provide easily self-administered relief from cigarette withdrawal. The NNS was tested for safety and efficacy in smoking cessation. Two hundred and fifty-five smokers were randomized to NNS or a piperine placebo. Drug use was limited to 8-32 doses/day for 6 months. Subjects were tested while smoking and at post-cessation daily (week 1) with follow-up at weeks 2, 3, 6 and at 3 months, 6 months and 1 year. Continuous abstinence analyses (CO < or = 8 ppm; no slips) showed that NNS significantly enhanced success rates over placebo overall (p < 0.001) and at all test intervals. Differences at key intervals between active and placebo were: 63% vs. 40% (day 5), 51% vs. 30% (week 3), 43% vs. 20% (6 weeks), 34% vs. 13% (3 months), 25% vs. 10% (6 months) and 18% vs. 8% (1 year). Side effects were common but tolerable. Cotinine measures showed that replacement of nicotine approximated 30% of smoking levels. Hazard functions revealed relapse risks peaked at day 1, day 5 and 3 weeks for strict abstinence. It is concluded NNS is safe, efficacious and a viable alternative treatment for smoking cessation.

Administration, Intranasal↗
PubMed1993

Effectiveness of nicotine patch and nicotine gum as individual versus combined treatments for tobacco withdrawal symptoms.

Nicotine gum and transdermal nicotine have been shown to relieve withdrawal and double success rates over placebo in trials of smoking cessation. This study tested whether combining the two methods would relieve withdrawal more effectively compared to either treatment alone. Twenty-eight smokers served as their own controls in each of four conditions: active gum + active patch (double active), active gum + placebo patch (gum only active), placebo gum + active patch (patch active) and placebo gum + placebo patch (double placebo). This "double placebo" design controls sensory, psychological and ritual variables associated with each drug form. Withdrawal symptoms were rated four times daily for 3 days in each condition. Total baseline (smoking) withdrawal scores using visual analogue scales (VAS) averaged 101.1. During cessation, total withdrawal increased to 187.0 for the double placebo condition, 142.2 for the active gum/placebo patch treatment and 128.3 for the active patch/placebo gum treatment. The double active condition equalled smoking with score 99.2. All pairwise comparisons were significant (P < 0.001) except between the two single active conditions and between smoking versus the double active condition. Significant time-of-day effects by treatment on withdrawal were observed for the double placebo condition (P < 0.05) with less withdrawal in the morning. The findings suggest: 1) combining nicotine gum with transdermal nicotine may be superior to either treatment alone, 2) more symptoms may be nicotine specific (relieved by replacement) than previously thought.

Administration, Cutaneous↗
PubMed1991

Combined use of alcohol and nicotine gum.

This study evaluated the effects of chewing nicotine gum immediately before and just after drinking a moderate amount of alcohol. Four research questions were addressed. First, does chewing nicotine gum prior to drinking alcohol attenuate the increased craving to smoke that is typically associated with alcohol use? Second, does drinking prior to chewing reduce the gum's effectiveness? Third, are significant side effects observed with nicotine gum, and is their severity affected by alcohol use? Finally, can we identify subjects who are more likely to respond well to the gum on the basis of smoking history or pattern or other descriptive-demographic, psychologic, or historical variables? Smokers who had abstained for at least 12 h were studied in a fully crossrandomized experimental design that contrasted nicotine gum (before or after drinking) versus sugarless gum, and alcohol versus a no-alcohol comparison condition. Nicotine gum use was associated with significantly greater immediate reduction in craving to smoke, regardless of whether it preceded or followed alcohol, but the effects were weak and short-lived in either case. Moderate use of alcohol after chewing the gum eliminated virtually all of its beneficial effects. Mild side effects were common with nicotine gum, but equally so regardless of alcohol use. A small battery of demographic and historical variables failed to identify those subjects who responded well to nicotine gum.

Adult↗
PubMed1990

Psychopharmacologic treatment of cigarette smoking.

In summary, the entrance of the dental community into this area of treatment may have a significant impact on the reduction of smoking in our society. Dentists may be seeing smokers before the onset of disease and when they are ready to quit. Repeated patient visits offer a unique opportunity for follow-up. Presently, nicotine polacrilex is the only approved pharmacological FDA treatment. This is an ideal treatment for dentists to pursue because it is orally administered and effective through a proper chewing action. Other pharmacological agents (for example, antihypertensives) may require the followup of the physician. There are three key demands on the practitioner treating smokers: an understanding of the role of nicotine dependence in compulsive smoking; how to prescribe and educate in the proper use of nicotine polacrilex; and sympathy and a basic awareness of withdrawal and the psychological needs of patients undergoing cessation from smoking. This paper covers the rationale for development and use of nicotine polacrilex as well as some of the evidence for its effectiveness (relief of nicotine withdrawal) and efficacy (short and long term). The specifics of proper use have been described along with a brief overview of the psychosocial skills needed to succeed. The dentist offers a unique opportunity to reach enormous numbers of smokers in the battle against tobacco-induced disease and death.

Behavior Therapy↗
PubMed1989

Measuring nicotine dependence: a review of the Fagerstrom Tolerance Questionnaire.

In the last decade, the importance of nicotine in maintaining smoking and in cessation difficulty has been acknowledged. Consequently, this has led to efforts to measure nicotine dependence. This paper focuses on a widely used, paper-and-pencil test of nicotine dependence--the Fagerstrom Tolerance Questionnaire (FTQ). The findings indicate that the FTQ correlates with other proposed measures of nicotine dependence (carbon monoxide, nicotine, and cotinine levels). The connection between FTQ scores and withdrawal symptoms is weak. In clinic outcome trials, the FTQ predicted success where no pharmacologic treatment was involved, while nicotine replacement appeared to mask the relation between FTQ scores and outcome. However, the FTQ may predict outcome with nicotine replacement as a function of dose. In placebo-controlled, nicotine replacement trials, FTQ scores were related to success by treatment. Problems with the FTQ are described with focus on item difficulties and analyses of the scale.

Drug Tolerance↗
PubMed1989

Competition/cooperation in worksite smoking cessation using nicotine gum.

Worksite competitions have shown promise in facilitating smoking cessation among employees, but the effectiveness of the competition component itself has not been determined. A multicomponent behavioral treatment and maintenance program plus nicotine gum were provided to competition and no-competition conditions at two large worksites. At 1-year follow-up, 100% of subjects were contacted and measurement of expired carbon monoxide validated abstinence. Recruitment rates were significantly higher in the competition group (2% of smokers) than the no-competition group (0.6% of smokers, P less than 0.001). One-year abstinence rates were 50% for the competition group and 25% for the no-competition group. This difference was not statistically significant (P less than 0.25). However, survival analysis revealed a significant difference in number of weeks abstinent during the year after treatment. Mean weeks abstinent was 35 for competition and 22 for no-competition (P less than 0.05). At the 3-month follow-up, the number of boxes of nicotine gum used predicted abstinence (P less than 0.002). At the 1-year follow-up, rated supportiveness of one's "buddy" (P less than 0.01) and number of sick days prior to starting the program predicted abstinence (P less than 0.003). It is suggested that competition, nicotine gum, and social support may enhance worksite smoking cessation program rates.

Adult↗
PubMed1985

Nicotine gum vs. placebo gum: comparisons of withdrawal symptoms and success rates.

Our data and that of researchers in the area clearly provide evidence for nicotine-specific withdrawal and its relief with nicotine gum. In addition, outcome efficacy is enhanced when nicotine gum is combined with behavioral treatment. Nicotine gum appears to be valuable both as a systematic tool and as a means of combatting short- and long-term nicotine seeking that contribute to maintenance of smoking and the inability to quit.

Body Weight↗
PubMed1984

Time course of smoking withdrawal symptoms as a function of nicotine replacement.

Subjects (N = 32) provided morning, afternoon, and evening data for week-1 withdrawal from smoking. Withdrawal symptoms were measured using Schneider's Smoker Complaint Scale. Twenty subjects received nicotine gum and 12 subjects received placebo gum. Carbon monoxide levels verified smoking abstinence. Results showed significantly less withdrawal for nicotine gum subjects compared to the placebo group. A significant treatment- x -time of day interaction was also observed: Placebo subjects reported increased withdrawal in the evenings compared to their morning and afternoon scores, and in contrast to nicotine-group responses. The results provide evidence for nicotine withdrawal and its alleviation by nicotine gum.

Adult↗